Device for providing a measured vertical dimension of occlusion

ABSTRACT

Devices and methods for treating respiratory problems of a subject, such as those related to sleep apnea, are presented herein. An implementation of a device may be configured to provide a measured vertical dimension of occlusion (VDO) and/or mandibular advancement in a subject. Methods for treating a subject through the use of the device may include systematically increasing and/or decreasing the measured VDO provided by the device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/023,795, filed Jul. 11, 2014, which is incorporated herein byreference.

FIELD OF THE DISCLOSURE

This disclosure relates to oral appliances used for the treatment ofsleep apnea that are configured to provide a predetermined verticaldimension of occlusion.

BACKGROUND

Sleep apnea occurs when a subject periodically stops breathing or hasdiminished breathing during sleep. Oral appliances may be used in thetreatment of sleep apnea. Oral appliances may have a mandibular portionthat contacts one or more mandibular teeth of a subject in an as-usedposition inserted into the mouth of the subject and a maxillary portionthat contacts one or more maxillary teeth of the user when in theas-used position. Oral appliances for treatment of sleep apnea may beconfigured to provide mandibular advancement of the subject for openingobstructions of the subjects upper airway.

SUMMARY

One or more aspects of the disclosure relate to a device for providing ameasured vertical dimension of positioning the jaw in a subject. Thevertical dimension of a positioning of the jaw may be referred to as“vertical dimension of occlusion” or, “VDO.” In some implementations,the device may be employed to modify an oral appliance used for thetreatment of sleep apnea. The device may comprise one or more tabsconfigured to be positioned between contact surfaces of a mandibularportion and a maxillary portion of a wearable oral appliance. Anindividual tab may be configured to be carried by one or more componentsof an oral appliance for operative positioning thereon. An individualtab may be formed with a thickness that provides a predetermineddisplacement of the mandibular portion from the maxillary portion whenthe oral appliance is worn by a subject.

Another aspect of the disclosure related to an oral appliance deviceconfigured to provide a measured VDO in a subject. The device maycomprise one or more of a maxillary portion having an upper cavityconfigured to receive one or more maxillary teeth of a subject, amandibular portion having a lower cavity configured to receive one ormore mandibular teeth of the subject, one or more connectors, one ormore tabs configured to be positioned between contact surfaces of themandibular portion and the maxillary portion, and/or other components. Agiven connector may have a first end configured for attachment to a partof a maxillary portion and a second end configured for attachment to apart of a mandibular portion. A given connector may be configured toadvance the mandibular portion forward of the maxillary portion. Theforward advancement may be configured to provide mandibular advancementfor the wearer of the device. An individual tab may be formed with apredetermined thickness that may provide a predetermined displacement ofthe mandibular portion from the maxillary portion when operativelypositioned on the device. An individual tab may be configured forattachment to the mandibular portion such that the mandibular portionmay carry the tab and/or facilitate an operative positioning thereon.The device may be used for the systematic treatment of sleep apneasufferers and/or other respiratory ailments.

These and other features and characteristics of the present technology,as well as the methods of operation and functions of the relatedelements of structure and the combination of parts and economies ofmanufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and in the claims, the singular form of “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exploded side view of a device configured toprovide a measured VDO, in accordance with one or more implementations.

FIG. 2 illustrates a top view of a maxillary portion of the device ofFIG. 1, in accordance with one or more implementations.

FIG. 3 illustrates a bottom view of the maxillary portion of the deviceif FIG. 1, in accordance with one or more implementations.

FIG. 4 illustrates a top view of a mandibular portion of the device ofFIG. 1, in accordance with one or more implementations.

FIG. 5 illustrates a bottom view of the mandibular portion of the deviceof FIG. 1, in accordance with one or more implementations.

FIG. 6 illustrates a connector configured to provide mandibularadvancement that may be configured for use with the device of FIG. 1, inaccordance with one or more implementations.

FIG. 7 shows a top view of a tab configured to be carried by amandibular portion of the device of FIG. 1, in accordance with one ormore implementations.

FIG. 8 shows a top view of a mandibular portion of the device of FIG. 1,in accordance with one or more implementations.

FIG. 9 illustrates an assembled side view of the device of FIG. 1, inaccordance with one or more implementations.

FIG. 10 illustrates a partial side view of a connector mount, inaccordance with one or more implementations.

FIG. 11 shows a view of the connector mount as illustrated in FIG. 10with a given tab in a seated attachment on the connector mount, inaccordance with one or more implementations.

FIG. 12 illustrates a top view of a connector mount of a mandibularportion of the device of FIG. 1 formed with a substantially T-shapedcross section, in accordance with one or more implementations.

FIG. 13 illustrates an exploded side view of a device for providing ameasured vertical dimension of occlusion, in accordance with one or moreimplementations.

FIG. 14 shows an assembled side view of the device of FIG. 13, inaccordance with one or more implementations.

FIG. 15 shows a top view of a mandibular portion of the device of FIG.13, in accordance with one or more implementations.

FIG. 16 illustrates a kit of tabs configured to provide a measured VDOin an oral appliance, in accordance with one or more implementations.

FIG. 17 illustrates a method of providing VDO in an oral appliance usedfor the treatment of sleep apnea, in accordance with one or moreimplementations.

DETAILED DESCRIPTION

FIG. 1 illustrates an implementation of a device 10 configured toprovide a measured vertical dimension of occlusion (VDO). VDO may referto a measure of displacement of the maxilla and the mandible of asubject when the maxillary teeth and the mandibular teeth are engagedwithin an oral appliance. By way of non-limiting example, a MandibularRepositioning Device (MRD) and/or other types of devices may beconfigured to hold the mandible forward in relationship to the maxilla.The device 10 described herein may be used for treating subjectssuffering from sleep apnea and/or other respiratory problems. Forexample, the device 10 be employed as an oral appliance, and/orcomponents of the device 10 may be used to modify existing oralappliance, to provide systemic application of vertical dimension ofocclusion for sleep apnea and/or other medical issues.

In one or more implementations, the device 10 may be a wearable oralappliance configured to be inserted into a mouth of a subject in anas-used position. The device 10 may be configured to provide apredetermined amount of mandibular advancement for a subject wearing thedevice 10. In some implementations, mandibular advancement (positioningthe jaw forward) may facilitate displacing a subject's tongue forward inthe mouth. By positioning the tongue in a forward position, thepharyngeal airway of the subject may be substantially opened and/or madeless obstructed as to reduce the occurrence of sleep apnea relatedrespiratory problems. One or more implementations of the device 10 mayfacilitate the addition and/or modification of a measured VDO. A givenVDO may facilitate further increasing an opening of the pharyngealairway and/or other advantages. A given VDO may facilitate one or moreof a further reduction of respiratory problems, improved comfort of thesubject wearing the device 10, and/or other advantages.

In some implementations, the device 10 may include one or more of amaxillary portion 12, a mandibular portion 28, one or more connectors46, one or more tabs 44 for providing a VDO, and/or other components (itis noted that the opposite side of the device 10 as that shown in FIG. 1may be a mirror image than that shown in FIG. 1, employing one or morelike components). As shown in FIG. 1, FIG. 2, and FIG. 3, the maxillaryportion 12 may comprise one or more of a substantially U-shaped body,and/or other components. The maxillary portion 12 may be formed from oneor more materials used in dentistry and/or other fields. By way ofnon-limiting example, the maxillary portion 12 may be formed from one ormore of methyl methacrylate compounds, carbon and nylon based polymers,and/or other materials.

In some implementations, the maxillary portion 12 may be configured toreceive at least some of the maxillary teeth of a subject for attachingthe device 10 in the as-used position inserted into the mouth of thesubject. The maxillary portion 12 may include one or more of a contactsurface 14, an upper cavity 16 being opposite the contact surface 14,one or more proximal ends 20, and/or a distal end 22. The upper cavity16 may be configured to receive and/or otherwise engage at least some ofthe maxillary teeth of a subject. In some implementations, receiving atleast some of the maxillary teeth or a subject may comprise seating theat least some of the maxillary teeth within the upper cavity 16 and/orother techniques for receiving teeth in the upper cavity 16. The uppercavity 16 may be formed by one or more of an outer sidewall 18, an innersidewall 19, and/or by other components of the maxillary portion 12. Insome implementations, the maxillary portion 12, upper cavity 16, and/orother portions of the upper cavity 16 (e.g., a liner disposed within thecavity, and/or other components, not shown in FIG. 1-3) may be formed ofmaterial configured to be molded and/or otherwise fitted to the teeth ofthe subject. Such material may include one or more of thermallyresponsive materials, plastics, polymers, and/or other materials. Athermally responsive material may comprise a material that, when heated(e.g., submerged in hot water and/or heated in other ways), the materialmay soften, and when placed in a mouth of a subject and the subjectbites down, the thermally responsive material may directly form toand/or around the subjects teeth and/or gums. The processes of forming athermally responsive material to a subject's teeth and/or gums may bereferred to as a ‘boil-and-bite’ process and/or other terms. Whencooled, the thermally responsive material may set and/or retrain animpression of the subject's teeth and mouth. For example, a thermallyresponsive material may comprise one or more of a soft acrylic,silicone, ethylene vinyl acetate, a thermal-forming polymer, and/orother materials.

In some implementations, the upper cavity 16 may be formed to the shapeand/or configuration of the maxillary teeth and/or gums of a user byother techniques. For example, an impression of the subject's teeth maybe taken and used as a mold to form the upper cavity 16.

In some implementations, the maxillary portion 12 may include one ormore opposing connector mounts 24. The one or more opposing connectormounts 24 may be disposed on opposing sides of the outer sidewall 18and/or other locations. The one or more opposing connector mounts 24 maybe positioned at or near the distal end 22 and/or other locations. Theconnector mounts 24 may be used for attaching the connector 46 betweenthe maxillary portion 12 and the mandibular portion 28. An attachment ofthe connector 46 between the maxillary portion 12 and mandibular portion28 may be configured to provide mandibular advancement (e.g., themandibular portion 28 may be maintained at a forward position relativeto the maxillary portion 12 via the connector 46). The connector mounts24 may include a receiving aperture 26 and/or other componentsconfigured to receive a first end 48 of the connector 46 and/or toattach it thereto. In some implementations, the attachment of the firstend 48 of the connector 46 to the aperture 26 may be one or more ofrotatable, fixed, and/or other types of attachment. By way ofnon-limiting example, in some implementations, the first end 48 mayinclude a pin with a flanged end (see, e.g., FIG. 6). The pin with theflanged end may be configured to lock and/or otherwise securely attachedthe first end 48 within the aperture 26. The use of the aperture 26 andpin with flanged end of the connector 46 is provided merely forillustrative purposes and is not intended to be limiting. In someimplementations, other techniques for attaching the connector 46 to themaxillary portion 12 may be employed to achieve a desired attachmenttype.

Referring now to FIG. 1, FIG. 4, and FIG. 5, the mandibular portion 28may comprise a substantially U-shaped body, and/or other components. Themandibular portion 28 may be formed the same or similar to the maxillaryportion 12. The mandibular portion 28 may be configured to receive atleast some of the mandibular teeth of a subject to facilitate attachmentof the device 10 within the mouth of the subject in the as-usedposition.

The mandibular portion 28 may include one or more of a contact surface30, a lower cavity 32 being opposite the contact surface 30, one or moreproximal ends 36, a distal end 38, and/or other components. The lowercavity 32 may be configured to receive and/or otherwise engage at leastsome of the mandibular teeth of a subject. Receiving and/or otherwiseengaging at least some of the mandibular teeth may comprise seating themandibular teeth within the lower cavity 32. The lower cavity 32 may beformed by one or more of an outer sidewall 34, an inner sidewall 36,and/or other components. In some implementations, one or more of themandibular portion 28, lower cavity 32, and/or other portions of thelower cavity 32 (e.g., a liner disposed within the cavity and/or othercomponents, not shown) may be formed of material configured to bemolded, formed, and/or otherwise fitted to the teeth of the subject.

The mandibular portion 28 may include one or more opposing connectormounts 40. The one or more opposing connector mounts 40 may be disposedon opposing sides of the outer sidewall 34 and/or other locations, Theone or more opposing connector mounts 40 may be positioned at or nearthe proximal ends 36. In some implementations, the one or more connectormounts 40 may be configured such that they may project a predetermineddistance from the outer sidewall 34. By way of non-limiting example, anindividual connector mount 40 may form a “wing” and/or other shapeextending from the outer sidewall 34. The one or more connector mounts40 may be configured to facilitate attachment of a connector 46 betweenthe maxillary portion 12 and the mandibular portion 28. A givenconnector mount 40 may include one or more of a receiving aperture 42configured to receive a second end 50 of the connector 46 to attach itthereto and/or other components. In some implementations, an attachmentof the second end 50 of the connector 46 to the aperture 42 may be oneor more rotatable, fixed, and/or other types of attachment. In someimplementations, the second end 48 may include a pin with a flanged end(see, e.g., FIG. 6) and/or other components. A pin with a flanged endmay be configured to lock and/or otherwise securely attach the secondend 48 with the aperture 42. In some implementations, an attachment ofthe second end 48 with the aperture 42 may be removable. The use of theaperture 42 and pin with flanged end of the connector 46 is providedmerely for illustrative purposes and is not intended to be limiting. Insome implementations, other techniques for attaching the connector 46 tothe mandibular portion 28 may be employed. By way of non-limitingexample, a mechanical fastener such as screws and/or other mechanicalfasteners may be used.

Referring now to FIG. 1, FIG. 7, and FIG. 8, a given tab 44 may beconfigured to provide a measured distance for a VDO of a subject wearingthe device 10 in an as-used position. The tab 44 may be formed from amaterial including one or more of a thereto-forming polymer used in thefabrication of dental prosthetics and/or orthodontic appliances,resilient polymers (e.g., that may provide an amount of “give”), hardpolymers, nylon polymers, and/or other materials. The tab 44 may beformed by one or more of injection molding, machining, and/or by othertechniques suitable for the intended purpose(s) presented herein. Thetab 44 may include one or more of a longitudinal slot 52 configured tofacilitate mounting of the tab 44 to a connector mount 44 of themandibular portion 28, and/or other components. For example, the slot 52may be sized as a clearance slot and/or other type of slot. The slot 52may be configured such that the tab 44 may be slid over the connectormount 44 prior to attachment of the connector 46 to the connector mount44. The tab 44 may be configured to be carried by the connector mount 44in an operative attachment. In some implementations, an individual tab44 may be substantially L-shaped, as shown in FIG. 7.

In some implementations, the tab 44 may include a layer of adhesive (notshown in FIG. 1, FIG. 7, and FIG. 8), and/or other components. A layerof adhesive may be coupled to and/or incorporated with a surface (e.g.,a surface that comes into contact with the contact surface 30 of themandibular portion 28). Adhesives and/or other components may beconfigured to facilitate operatively attachment of the tab 44 to themandibular portion 28 and/or maxillary portion 12. The tab 44 mayinclude a backing (not shown in FIG. 1, FIG. 7, and FIG. 8) that may beremoved to expose an adhesive. In some implementations of the tab 44including an adhesive layer, the slot 52 may or may not be omitted. Forexample, if the slot 52 is omitted, the tab 44 may need not be carriedby the connector mount 44. Instead, the tab 44 may be adhered to themandibular portion 28 and/or maxillary portion 12 as needed.

In some implementations, the slot 52 may be configured to have apredetermined length. The slot 52 may be configured such that the tab 44may be attached to the connector mount 40 with minimal force by a user.By way of non-limiting example, the slot 52 may be formed in accordancewith a known or standardized width of the connector mount 40. In someimplementations, the slot 52 may have a length that is less than a knownwidth of the connector mount 40. For example, a user (e.g., a dentalpractitioner and/or other user) may form the slot 52 to a desired length(e.g., by cutting, sanding, scraping, and/or other slot formingtechniques) such that the tab 44 may fit over the connector mount 40with minimal force applied by the user. In some implementations, theslot 52 may have a length that is equal to or slightly less than a knownwidth of the connector mount 44. By way of non-limiting example, theslot 52 may be configured such that the tab 44 may be carried in africtional engagement by the connector mount 44 that may require atleast some applicative force by a user to slide the tab 44 into itsoperative engagement with the connector mount 40.

Referring now to FIG. 1, in some implementations, a given tab 44 mayhave a. predetermined thickness “T” that may provide a predetermineddisplacement of the mandibular portion 28 relative the maxillary portion12 (e.g., a VDO) when the device 10 is in an as-used position in themouth of the subject. For example, in some implementations, thethickness “T” may be in the range of 0.1 to 10, and/or other ranges. Insome implementations, the thickness “T” may be in the range of 0.5 to 3millimeters, and/or other ranges. In some implementations, the thickness“T” of the tab 44 may be 1 millimeter and/or other thickness.

In some implementations, the connector mounts 40 may be configured toreceive multiple tabs 44 in a stacked arrangement carried by a givenconnector mount 40. A user may selectively employ one or more given tabs44 with the device 10 based on a given thickness of a single tab 44and/or a cumulative thickness of multiple tabs 44. One or more methodsof treating a subject suffering from sleep apnea by modifying an oralappliance that may be formed the same or similar to device 10 aredescribed in more detail herein.

In some implementations, the tab 44 may include one or more of aprotruding contact portion 54 and/or other components. A protrudingcontact portion 54 may be configured for operative positioning betweenthe contact surface 14 of the maxillary portion 12 and the contactsurface 30 of the mandibular portion 28, as shown in FIG. 9. In someimplementations, the tab 44 may be configured such that the contactportion 54 may be positioned at or near the molars and/or other teeth ofthe subject when the device 10 is in the as-used position (anapproximate area where the molars may be positioned is shown by thedashed ellipse). Operative positioning of the contact portion 54 withinthe area of dashed ellipse and/or other area may provide improvedcomfort to the wearer.

FIG. 10 and FIG. 11 illustrate an implementation of the device 10configured to facilitate a seated attachment of the tabs 44 to theconnector mounts 40. By way of non-limiting example, a seated attachmentmay correspond to a “snap fit” type attachment and/or other types ofattachment. A given connector mount 40 may include one or more of one ormore detents 56 (e.g., one detent 56 and/or two opposing detents 56 asshown) disposed on one or more side edges (e.g., a first side edge 41and/or second side edge 43) of a connector mount 40 and/or othercomponents. In some implementations, the detents 56 may form a width “W”of the connector mount 40. The width “W” associated with the detents 56may be less than a width associated with a distal end 45 of theconnector mount 40. In some implementations, the width “W” may be formedto be the same or similar to a length “L” of the slot 52 (shown indashed lines) formed in a given tab 44. Due to the malleability of thematerial forming the connector mount 40 and/or the distal end 45, thedistal end 45 may deflect as the tab 44 is slid over the connector mount40 to compensate for the lesser width of the slot 52 until the slot 52is seated over the detents 56 (e.g., the tab 44 snap-fits onto theconnector mount 40). In some implementations, the width W and length Lmay be standardized lengths. Such standardization may allow fordifferent devices that have varying geometries of the mandibular portion28 and/or maxillary portion 12 and/or other oral appliances havingconnector mounts the same or similar as those shown, to commonly employthe tabs 44 of the presented invention.

FIG. 12 illustrates an implementation of the device 10 wherein theconnector mounts 40 of the mandibular portion 28 may be formed having anon-linear cross section. For example, a given connector mount 44 mayhave a substantially T-shaped cross section, and/or other non-linearcross section (e.g., curved, star shaped, and/or other shapes). In theimplementation shown, the tabs 44 of the device 10 may be formed havinga slot 52 being similarly shaped to the cross-section of the connectormount 40. For example, the slot 52 may be a T-shaped slot and/or othershaped slot configured to match the T-shaped cross-section and/or othershape cross-section of the connector mount 40. The non-linear crosssection of the mount 44 and/or matching shape slot 52 may be configuredto facilitate operative mounting of the tab 44 to the connector mount 40with the tab 44 and/or connector mount 40 registered in positions inaccordance with the corresponding shapes. As such, forming of the slot52 and connector mount 40 to have non-linear cross sections may ensurethat the tab 44 may be in a particular registration orientation foroperative mounting to the connector mount 40 (e.g., to ensure the slot52 and connector mount 40 are correctly aligned). This may furtherensure that the contact portion 54 may be positioned in a desiredlocation and/or orientation between the contact surfaces (30, 14) of themandibular portion 28 and maxillary portion 12. By way of non-limitingexample, this may ensure that the contact portion 54 is properly locatedover the molars and/or other teeth of a subject. It is noted that theT-shaped cross sections as currently shown are for illustrative purposesonly and is not intended to be limiting. In other implementations, theconnector mounts 40 and/or slots 52 of the tabs 44 may be formed havingother shapes and/or cross sections.

FIG. 13, FIG. 14, and FIG. 15 illustrate an implementation of the device10 wherein the connector mounts 40 of the mandibular portion 28 may bepositioned on opposing sides of the outer sidewall 34 at or near thedistal end 38, and/or the connector mounts 24 of the maxillary portion12 may be positioned on opposing sides of the outer sidewall 18 at ornear the proximal ends 20. The current implementation facilitates atechnique in which mandibular advancement may be accomplished, e.g., theconnection of the mandibular portion 28 with the maxillary portion 12via the connector 46 that positions the mandibular portion 28 forward ofthe maxillary portion 12. In the implementation shown, the connectormounts 40 of the mandibular portion 28 may be formed into the outersidewall 34 as a uniform object. The connector mounts 24 of themaxillary portion 12 may similarly be formed in the outer sidewall 18.

The connector mounts 24, 40 may include receiving apertures 26, 42,respectively, configured to attach to ends of the connector 46. Forexample, the ends of the connector 46 may include pins with flanged endsand/or other components. In some implementations, other techniques forattaching the ends of the connector 46 to the connector mounts 24, 40may be employed. For example, the ends of the connector 46 may beattached to the connector mounts 26, 40 using screws and/or otherfasteners. In the some implementations, the tabs 40 may be carried bythe connectors 46. For example, the connectors 46 may extend through theslots 52 of the tabs 44 so as the contact portions 54 are substantiallypositioned at or near the proximal ends 36 as illustrated in FIG. 15.

Referring to FIG. 15, in some implementations, a first end 57 of a giventab 44 may include a slit 55 and/or other components. The slit 55 maycommunicate through a side edge of the tab 44 to the slot 52. The slit55 may be configured to facilitate splaying of the first end 57 by theuser. In some implementations, the given tab 44 may be configured toattach to the connectors 46 by splaying the first end 57. Splaying thefirst end 57 may expose the slot 52 such that the connector 46 may becommunicated through the slit 55 and into an operative positioning onthe device 10. The provision of a slit 55 on a given tab 44 mayalleviate the need to detach the connectors 46 from the mandibularportion 28 and/or maxillary portion 12 and feed the connectors 46through the slot 52 to achieve the operative attachment thereof.

In some implementations, a slit 55 may have a width that is less thanthe width of a given connector 46. In some implementations, the width ofthe slit 55 may gradually taper from a first end at its widest opening(adjacent the side edge of the tab 44) to a second end at its narrowestopening (adjacent the slot 52). In some implementations, the widestopening may be substantially equal to the width of the connector 46while the narrowest end may be substantially less than the width of theconnector 46. As such, the tapered slit 55 may assist the user inguiding the tab 44 in its engagement with the connector 46. A taperedslit 55 may further be configured to provide a type of “snap fit”attachment of the tab 44 to a connector 46. It is noted that theimplementation of the tab 44 shown in FIG. 15 may be employed with oneor more of the implementations of the device 10 described herein andshould not be considered limited by the depiction in FIG. 15.

FIG. 16 illustrates an implementation of a kit 60 comprising one or moretabs 44 for use with the device 10 and/or other oral appliances. In someimplementations, the kit 60 may include one or more tabs 44 and/or othercomponents. Individual tabs 44 may vary by one or more of thickness,size, dimension, configuration, slot length, slot width, slot shape,contact portion dimensions, contact portion surface area, color, and/orother variances.

By way of non-limiting example, tabs of a common thickness, size,dimension, configuration, slot length, slot width, slot shape, contactportion dimensions, contact portion surface area and/or other aspect maybe color coded to a similar color for easy recognition of like tabs. Byway of non-limiting example, individual tabs of a first thickness may bea first color while individual tabs of a second thickness may be asecond color different from the first color. Thicknesses of one or moretabs may be distinguishable from thicknesses of one or more other tabsbased on the assigned color. In some implementations, a reference chartmay be provided to a user that may describe a color-to-thicknessrelationship. In some implementations, a prescribed thickness of a giventab may be provided as indicia imparted on at least one surface of thegiven tab. In some implementations, tabs sharing a common thicknessand/or other common configuration may be provided in the kit 60 in pairsand/or other quantities.

In some implementations, the kit 60 may include one or more mandibularportions 28 (not shown in FIG. 16), one or more maxillary portions 12(not shown in FIG. 16), one or more connectors 46 (not shown in FIG.16), and/or other components. In some implementations, the kit 60 mayinclude one or more tabs 44 that may be of the same or substantially thesame thickness, size, dimension, configuration, slot length, slot width,slot shape, contact portion dimensions, contact portion surface area,and/or other similarities.

In some implementations, the kit 60 may be provided in a sterilepackaging, and/or other types of packaging. In some implementations, thekit 60 may be provided to a user that allows the user to selectivelyemploy the desired tabs 44 as needed for treatment of sleep apnea of asubject and/or for other purposes. In some implementations, the kit 60may be provided as part of a therapy regime. For example, a method oftreating sleep apnea by providing VDO with an oral appliance may includesteps for modifying a measured amount of VDO by selectivelyinterchanging, shacking, and/or otherwise employing one or more tabs 44during predetermined periods of use of the oral appliance (e.g., such asthe device 10).

FIG. 17 illustrates a method 100 of providing a measured VDO in asubject using an oral appliance, in accordance with one or moreimplementations. The operations of method 100 presented below areintended to be illustrative. In some embodiments, method 100 may beaccomplished with one or more additional operations not described,and/or without one or more of the operations discussed. Additionally,the order in which the operations of method 100 are illustrated in FIG.17 and described below are not intended to be limiting. In someimplementations, method 100 may be implemented at least in part usingone or more tabs the same or similar to the tabs 44 employed in thedevice 10 and/or other components of the device 10 shown and describeherein.

Referring now to method 100 in FIG. 17, at an operation 102, anassessment of a severity of sleep apnea of a subject may be performed.In some implementations, the assessment may be performed using avalidated sleep testing device and/or other components and/ortechniques. For example, a home sleep testing device may comprise adevice provided by Res Med, called the Apnea Link®, and/or other devicesmay be employed, By way of non-limiting example, an assessment may beperformed using one or more devices employed for clinical studies suchas full laboratory based polysomnography, the Watch PAT device providedby Itamar Inc. and/or other devices. In some implementations, anassessment may be performed to determine an amount of apneic events perhour that are experienced by the subject, and/or may determine otherinformation.

In some implementations, assessment of the severity of sleep apnea maybe performed by taking X-rays of a subject and/or evaluating a positionof a hyoid bone. In particular, as the hyoid moves superiorly, thetongue may moves superiorly as well. Such movement may result in acrowding in the oral cavity and/or a positive impact upon theapnea-hypopnea index of the subject. With each addition of verticalspacing the posterior airway space adjacent the hyoid bone may bemeasured to provide different iterations of assessment.

In some implementations, treatment of sleep apnea may aim to reduce anoccurrence of apneic events experienced by the subject and/or to reducea degree of oxygen desaturation associated with apneic events. In someimplementations, a sleep test may be used to determine an “untreated” orbaseline amount of apneic events experienced by the subject and/or adegree of oxygen desaturation. Therapy may be applied in a manner whichaims to reduce the amount of apneic events to an acceptable level. Theacceptable level may vary from subject to subject. In someimplementations, a reduction of 50% or more from the baseline amount ofapneic events may be considered an acceptable level. However, dependingon the subject's severity, a reduction of less than 50% may beconsidered successful treatment. In some implementations, the acceptablelevel of apneic events in a subject may be at or below 10 events perhour and/or other amount. By way of non-limiting example, an acceptablelevel may be between 5 and 15 events per hour, and/or other ranges. Itmay be recommended that, in healthy individuals, a level of hypoxemiashould not drop below 90% O2 saturation of blood for more than 1% of thenight while sleeping.

In some implementations, a device-implemented assessment may beaccompanied by a questionnaire, and/or interview conducted with thesubject. The interview and/or questionnaire may include questions suchas “Do you snore?”, “Do you feel sleepy/tired during the day?”, “Do youawaken several times during the night?”, and/or other questions used forpurpose of assessing the severity of sleep apnea in a subject. Thequestionnaire and/or interview may further aid a practitioner inassessing the severity of sleep apnea of the subject.

At an operation 104, based on the assessment performed at operation 102,a mandibular advancement therapy regime may be prescribed for thesubject. For example, the therapy regime may be associated with the usean oral appliance configured to provide mandibular advancement of thesubject and/or other types of treatment. In some implementations, thetherapy regime may be prescribed that includes an oral appliance havingone or more of a maxillary portion, a mandibular portion, and/or one ormore connectors that may be the same or similar to the maxillary portion12, the mandibular portion 28, and/or the connectors 46 (shown in FIG.1-15 and described herein), and/or other components.

Oral appliances for mandibular advancement may increase pharyngeal widthat all levels in both the upright and supine positions. In someimplementations, the use of an oral appliance for mandibular advancementmay shorten the distance between the mandible and hyoid bone compared towhen it is not used (which may be evaluated, for example, using X-raysof the subject). A reduction in distance between the mandible and hyoidbone may be a critical area to assess during treatment. For example, ifthe subject is not responding, optimally to the mandibular advancementtreatment, the hyoid bone may need to be taken into consideration. As asolution described herein, augmenting a VDO in the oral appliance maycreate more space for the tongue and enable a larger airway dimension.

In some implementations, the mandibular advancement therapy regime mayinclude instructing the subject to wear the oral appliance for one ormore nights. The mandibular advancement provided by the oral appliancemay be at an initial displacement during a first night. The mandibularadvancement may be adjusted (e.g., increased, decreased, and/or adjustedin other ways) upon each successive night, in amounts depending on thetherapy as prescribed by a practitioner.

By way of non-limiting example, a first night of wearing the oralappliance may include providing a connector that provides a mandibularadvancement of 1 millimeter and/or other amount. Successive nights mayinclude increasing the displacement. This may be performed up until noappreciable improvement in the sleep apnea of the patient may be seenand/or until a maximum tolerance for the displacement is reached (e.g.,based on comfort and/or other factors). For example, a maximum toleranceof mandibular advancement may be from 5 to 15 millimeters, and/or otherranges. When maximum tolerance is reached, and/or when no appreciableimprovement in sleep apnea using mandibular advancement techniques maybe seen (e.g., no reduction of the occurrence of apneic events perhour), application of VDO may be provided using the oral appliance. Forexample, additional sleep tests may be conducted during the therapy todetermine whether there is a decrease in apneic events and/or oxygendesaturation while using the oral appliance. The sleep test maycomprise, for example, application of a sleep test device, aquestionnaire and/or interview conducted with the subject, and/or otherdevices and/or techniques. Other tests may be employed where theposition of the hyoid bone may be assessed.

At an operation 106, in response to determining that no appreciableimprovement in sleep apnea is seen through mandibular advancement and/orthe subject has reached their maximum mandibular advancement tolerance,the oral appliance may be modified to include VDO. The modification ofthe oral appliance may be accompanied by one or more nights of sleeptesting. For example, the number of apneic events, amount of oxygendesaturation, and/or position of the hyoid bone may be assessed over theone or more nights of sleep testing.

In some implementations, a subject may be provided an oral applianceconfigured to provide VDO, and/or the oral appliance used for mandibularadvancement may be modified to provide a measured VDO. By way ofnon-limiting example, during a first night, the oral appliance may bemodified and/or otherwise configured to provide a 1 to 3 millimeter,and/or other ranges, of VDO. By way of non-limiting example, a femalesubject may be prescribed 1 millimeter (or other amount) of VDO on agiven night of therapy. By way of non-limiting example, a male subjectmay be prescribed a 2 millimeter (or other amount) of vertical dimensionof occlusion on a given night of therapy.

In some implementations, during a second night of modifying the oralappliance associated with operation 106, the oral appliance may befurther modified and/or otherwise configured to provide an additional1-2 millimeters (and/or other range) of VDO. Modification may includeone or more of adding tabs in stacked arrangements, interchanging tabswith tabs of greater thickness, and/or may include one or more othertypes of modifications. By way of non-limiting example, a female subjectmay be prescribed an additional 1 millimeter (or other amount) of VDOusing the oral appliance on a second night (e.g. with a total of 2millimeters and/or other amounts). As another non-limiting example, amale subject may be prescribed an additional 1 millimeter (or otheramount) of VDO using the oral appliance on a second night (e.g., with atotal of about 3 millimeters and/or other amounts).

In some implementations, operation 106 may be performed using one ormore tabs the same or similar to tabs 44 (shown in FIG. 1, FIG. 7-16 anddescribed herein). In some implementations, operation 106 may beperformed using a device the same or similar to the device 10 (shown inFIGS. 1-16 and described herein).

At an operation 108, results of the sleep tests performed during theapplication of VDO (e.g. over two nights as presented, and/or otherdurations) may be evaluated to determine if there may be improvements insleep apnea of the subject. In some implementations, operation 108 maybe performed using a sleep testing device and/or other devices and/ortechniques. In some implementations, operation 108 may be performedusing techniques for assessing the position of the hyoid bone and/ortechniques.

By way of non-limiting example, determinations of improvement mayinclude determining one or more of if the amount of apneic events hasreduced down to an acceptable level for the subject; oxygen desaturationhas reduced down an acceptable level for the particular subject, and/orother operations.

In some implementations, assessing a position of the hyoid bone mayprovide insights into an amount of opening of an airway (e.g., posteriorairway space) of the subject. The amount of opening may indicate one ormore of a successful treatment, a need to provide additional VDO, and/orother outcomes. By way of non-limiting example, a measure of a posteriorairway space may be taken at intervals of the modifications to the VDOprovided by the oral appliance. In some implementations, 9 to 13millimeters and/or other ranges of hyoid elevation may be achieved withone or more of mandibular advancement in the range of 2 to 4 millimetersand/or other ranges, a vertical dimension in the range of 1 to 15millimeters and/or other ranges, and/or other applications of therapy.

At an operation 110, additional modification to the oral appliance maybe provided. For example, over one or more additional nights ofemploying the modified oral appliance, additional 0.5 to 1 millimeter(and/or other ranges) increments of VDO may be provided. In someimplementations, operation 110 may be performed using one or more tabsthe same or similar to tabs 44 (shown in FIG. 1, FIG. 7-16 and describedherein) and/or other components. In some implementations, operation 110may be performed using a device the same or similar to the device 10(shown in FIGS. 1-16 and described herein), and/or other components.

At an operation 112, one or both of operations 108 and/or 110 may berepeated one or more times. In some implementations, operations 108and/or 110 may be repeated until a target result may be obtained. Atarget result may correspond to one or more of apneic events per hourmeeting and/or beating an acceptable level for a given subject, oxygensaturation being at an acceptable for a given subject, posterior airwayspace being at an acceptable level for the given subject, the subjectreaching their maximum comfortable jaw position, and/or other results.The determination of the subject reaching their maximum comfortable jawposition may be determined subjectively through interviewing thesubject, through participation of the subject in a questionnaire, and/orby other techniques.

In some implementations, a method of improving comfort in a patientemploying an oral appliance may be accomplished using one or more tabs44 and/or other components of the device 10 as presented herein, and/orother components. For example, after prescribing a subject to amandibular advancement therapy using an oral appliance, an assessment ofthe comfort level of the subject may be performed. Several types ofcomplaints may be alleviated by adding VDO to their appliance. Forexample, subjects may suffer discomfort due to one or more of pain inone or both sides of the temporomandibular joint areas; pain in one ormore teeth, most likely due to clenching, bruxism and/or other issues;soreness in the tongue and/or inner cheek surfaces; and/or other comfortissues. In one or more scenarios, as well as during an occurrence ofother issues, the oral appliance may be modified by adding 1-5millimeters (and/or other amounts) of VDO. For example, the oralappliance may be modified to include 3 millimeters and/or other amountsof VDO. Generally, if pain is mild, the subject may be prescribed toemploy a modified VDO immediately (e.g., the same night). If pain ismoderate or more, the subject may be instructed to discontinue usingtheir appliance for 3 days (and/or other amount of days) before wearinga modified appliance. At a subsequent contact by a dental practitionerwith the subject (e.g., a few days, weeks, or months later), asubsequent assessment of the comfort level of the subject may beevaluated. In some implementations, if the subject continues toexperience pain (e.g., improved, but pain may be lingering), the oralappliance may be further modified to include an additional 0.5-2millimeters of VDO and/or other ranges. The operations of assessingcomfort and/or adding additional increments of VDO may be repeated untilmaximum conform may be achieved.

Although the present technology has been described in detail for thepurpose of illustration based on what is currently considered to be themost practical and preferred implementations, it is to be understoodthat such detail is solely for that purpose and that the technology isnot limited to the disclosed implementations, but, on the contrary, isintended to cover modifications and equivalent arrangements that arewithin the spirit and scope of the appended claims. For example, it isto be understood that the present technology contemplates that, to theextent possible, one or more features of any implementation can becombined with one or more features of any other implementation.

What is claimed is:
 1. A device configured to provide a measuredvertical dimension of occlusion in a subject, the device comprising: anoral appliance having a portion including a cavity configured to receiveand/or engage teeth of the subject, the portion further including acontact surface opposite the cavity; and a tab configured to removablyengage with the portion of the oral appliance at a mounting area of thecontact surface which spans a length of one or two teeth.
 2. The deviceof claim 1, wherein the mounting area of the contact surface spans thelength of one or more of a single molar, two molars, a molar and apremolar, or two premolars.
 3. The device of claim 1, further comprisinga mounting component configured to facilitate the removable engagementof the tab to the mounting area of the contact surface.
 4. The device ofclaim 3, wherein the mounting component comprises adhesive.
 5. Thedevice of claim 3, wherein the mounting component comprises a mechanicalfastener.
 6. The device of claim 1, wherein the tab has a thickness in arange of 0.1 to 10 millimeters.
 7. The device of claim 1, wherein thetab has a thickness in a range of 0.5 to 3 millimeters.
 8. The device ofclaim 1, wherein the tab has a thickness of 1 millimeter.
 9. The deviceof claim 1, further comprising: a second portion of the oral appliance;a connector, the connector comprising a first end configured to attachto the portion of the oral appliance, and a second end configured toattach to the second potion of the oral appliance; and wherein tab isconfigured to removably engage the portion of the oral appliance betweenrespective contact surfaces of the portion and the second portion, thetab being formed with a thickness that provides a predetermineddisplacement of the portion from the second portion.
 10. The device ofclaim 1, wherein the tab further comprises: a first surface; a secondsurface opposite the first surface; and a side edge communicatingbetween the first surface and the second surface, the side edgetraversing a periphery of the tab defining an outline of the tab. 11.The device of claim 10, wherein the outline of the tab forms a roundedrectangle shape.